MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number C01A-J

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in us but a similar device with product number c01a with 510(k)# k041584 and udi (b)(4) is marketed in us.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via a field contact regarding a patient with a pre-operative diagnosis of primary osteoporosis, undergoing a spinal therapy for a compression fracture.It was reported that due to a malfunction, the cement could not be mixed well and it took a long time, and the cement hardened abnormally quickly, before it was inserted into the body, so a new mixer, kit, and cement were opened.The cement was mixed for about 50 seconds.The cement did not come in contact with the patient.The procedure was performed successfully by using a new product.There was a delay of less than 60 mins.There were no patient symptoms/complications.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.Levels implanted: l5 after putting the monomer polymer in the reported mixer, inserted the stirring paddle and attempted to mix it, but even though the head was turned, the blade part did not work together and did not turn at all.Therefore, it was tried to mix the cement with a plunger forcibly and injected cement into bfd, but it hardened immediately and could not be extruded.Therefore, a new set was opened and used, and the operation was completed without any problems.The malfunction with the cement was that it hardened quickly.Only the mixing paddle will be returned.Others have been discarded.Procedure: bkp the mixer paddle in (b)(6) hospital was scheduled to be sent to tac because it was a defective product, and the sales rep had prepared to collect the product with the distributor, but the product had been discarded in the hospital.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; SZ 2000
• Manufacturer (Section G): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; SZ 2000
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11775135
• MDR Text Key: 249034008
• Report Number: 2953769-2021-00018
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1